The present invention relates generally to containers that are specifically adapted to hold materials to be sterilized by being subjected to heat. More specifically, it relates to bags that are subjected to autoclaving temperatures and pressures and are specifically designed to hold surgical or dental instruments.
Particularly in view of the recognition that viruses and bacteria, such as the HIV virus, may be transferred from a medical care provider to a patient, or vice-versa, it is commonplace to sterilize medical and dental instruments before they are to be used. Thus, a variety of bags have been designed in order to contain surgical and dental instruments, after which the bags are subjected to high temperatures in a heat chamber. That chamber is referred to hereinafter as an autoclave, although there may be definitions of that term which are not precisely met, e.g., the heating chamber may not be at superatmospheric pressure.
Autoclave bags must have several features which are necessary in order to have them function effectively, and other features that are highly desirable from the standpoint of economy. For example, an autoclave bag must have sufficient strength to resist ripping or tearing in use. Associated therewith is the property that it must be puncture-resistant, specifically where it is to hold surgical instruments, such as scalpels or other pointed devices. Yet any bag that holds surgical instruments is subject to being punctured when the bag is removed from the autoclave and, of necessity, instruments inside the bags shift. Such shifting makes the bag subject to being ripped or torn by the weight and movement of the medical instruments within the bag. When a bag tears, and the medical instrument comes into contact with surrounding surfaces, there is a concomitant loss of sterility of that instrument. Should the tearing take place to such an extent that the instruments fall from the bag, the instruments may well be damaged and, of course, their loss of sterility would be assured.
Many existing autoclave bags have to be ripped open for a person to gain access to the instruments therein. Such ripping often causes the instruments to scatter on trays because the force necessary to open such a bag is considerable, and such scattering contributes to loss of sterility. Also, many autoclave bags presently in use will still be wet when the autoclave is opened at ambient, atmospheric pressure. The only way to avoid the bag still being wet is if it goes through a drying cycle, which is often omitted because the person handling the autoclave wishes to retrieve the instruments for immediate use. If there is a paper backing on the autoclave bag and a door to the autoclave is opened while that backing is wet, the instruments therein will no longer be sterile. This is also the case if the paper backing becomes wet or acquires moisture from any source subsequent to autoclaving.
In addition to the need for a puncture-resistant, strong auto-clave bag, it is also highly desirable that an autoclave bag be reusable. Obviously, those autoclave bags that are opened by ripping or tearing are subject to use only once. Yet there is an environmental objective in having bags be reusable for perhaps one hundred times, thereby requiring less plastic waste to go into land fills.
Still another feature that is important in an autoclave bag is flexibility. If the bag or other container for surgical instruments is rigid, there is an increased possibility that shifting of the surgical instruments within the container will increase the likelihood that rigid walls will be punctured by a sharp instrument. Yet the bag wall must have sufficient strength so that it will be enable to resist puncture and yet be flexible. Thus, it is a goal to have an autoclave bag that has all the requisite features that will enable the bag to be maintained in use without the disadvantages inherent in the prior art.
It is, accordingly, a primary object of the present invention to provide an autoclave bag that is reusable, puncture-resistant and of such inherent strength that it does not rip or tear in use, yet is flexible. Surgical instruments may be placed within such a bag and the bag subjected to high autoclaving temperatures and pressures. After removal of the bag from the autoclave, the surgical instruments can be readily removed from the bag without contamination, and the bag can then be reused to subject another batch of surgical instruments to autoclaving conditions.